Contract development

We are delighted to provide services relating to the development of finished formulations of pharmaceuticals including CTD Drug Master Files.

Final dossage form development

  • Development and validation of technology Final Dossage Form – sterile liquid and lyophilized vials
  • Development and validation of analytical methods according to Ph.Eur., USP and Russian Pharmacopoeia requirements
  • Development of Final Dosage Form Registration documentation for EU countries (CTD format)

Stability studies for Final Dosage Form according to ICH guidelines

  • Development and validation of synthesis technology
  • Development and validation of analytical methods
  • Development of Active Substance Master Files and Veterinary Master Files
  • Stability studies according to ICH guidelines
  • Small batch size scale-up and routine manufacturing